Amlodipine-Borimed - Instructions For Use, Reviews, Price Of Tablets

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Amlodipine-Borimed

Amlodipine-Borimed: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews Amlodipine-Borimed
19. 19. Price in pharmacies

Latin name: Amlodipine-Borimed

ATX code: C08CA01

Active ingredient: amlodipine (Amlodipine)

Manufacturer: JSC "Borisov Plant of Medical Products" (JSC "BZMP") (Republic of Belarus)

Description and photo update: 2020-14-05

Prices in pharmacies: from 28 rubles.

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Amlodipine-Borimed is an antianginal and antihypertensive drug; selective BMCC (slow calcium channel blocker) of the third generation, mainly affecting the vessels.

Release form and composition

Dosage form - tablets: flat-cylindrical, beveled, white; on tablets with a dosage of 5 mg there is a risk, the functional purpose of which is to divide the tablet into two halves, equal in dosage [10 pcs. in blister strip packaging made of PVC film (polyvinyl chloride) and aluminum foil; in a cardboard box 3 or 6 blisters and a leaflet with instructions for the use of Amlodipine-Borimed].

Composition for 1 tablet (5/10 mg):

• active substance: amlodipine (in the form of amlodipine besylate) - 5 or 10 mg;
• excipients: potato starch - 19.965 / 19.965 mg; pregelatinized starch - 7.92 / 7.92 mg; calcium stearate - 1.65 / 1.65 mg; colloidal silicon dioxide - 2.97 / 2.97 mg; microcrystalline cellulose - 30.03 / 30.03 mg; calcium hydrogen phosphate dihydrate - 95.52 / 88.575 mg.

Pharmacological properties

Pharmacodynamics

The active ingredient in Amlodipine-Borimed is amlodipine, which is BMCC, is part of the group of dihydropyridine derivatives, has antianginal and hypotensive effects. By blocking calcium channels, it reduces the transport of calcium ions across the cell membrane (to a greater extent to vascular smooth muscle cells than to cardiac muscle cells).

The antianginal efficacy of the drug is based on its ability to dilate the coronary and peripheral arteries and arterioles, which in angina pectoris reduces the severity of restriction of the coronary blood supply. Expansion of peripheral arterioles reduces total peripheral vascular resistance (OPSR), heart afterload, and heart muscle oxygen demand. The expansion of the coronary arteries and arterioles both in the unchanged and in the ischemic zones of the myocardium leads to an increase in the supply of oxygen to the heart muscle (especially in patients with vasospastic angina pectoris, including those caused by smoking), and also prevents coronary artery spasm. With stable angina pectoris, taking a single daily dose of amlodipine increases the patient's tolerance to physical activity. Amlodipine-Borimed delays the development of angina pectoris and ischemic ST segment depression, reduces the frequency of angina attacks, as a result of which the need for nitroglycerin and other nitrates is reduced.

The antihypertensive effect of amlodipine is long-term and dose-dependent. Its hypotensive effect is determined by a direct vasodilating effect on the smooth muscles of the blood vessels. For patients with arterial hypertension, taking a single dose of the drug provides a clinically significant decrease in blood pressure (blood pressure) within 24 hours (in the supine and standing position). Excessive pressure reduction during the transition to an upright position (orthostatic hypotension), as a result of the use of amlodipine, is quite rare. It does not reduce exercise tolerance and left ventricular ejection fraction, does not affect the contractility and conductivity of the heart muscle, does not contribute to a reflex increase in heart rate (heart rate), inhibits platelet aggregation, reduces left ventricular myocardial hypertrophy,increases GFR (glomerular filtration rate), has a weak natriuretic effect.

Reception of Amlodipine-Borimed in patients with diabetic nephropathy does not lead to an increase in the severity of microalbuminuria. The drug does not adversely affect the plasma lipid concentration and metabolism; it can be taken by patients with diabetes mellitus, bronchial asthma and gout. A clinically significant decrease in blood pressure is noted after 6-10 hours, the duration of antihypertensive action is up to 24 hours.

In diseases of the cardiovascular system, including angina pectoris, coronary atherosclerosis with lesions from one vessel to stenosis of 3 or more arteries, atherosclerosis of the carotid arteries, after myocardial infarction, after PTCA (percutaneous transluminal coronary angioplasty) of coronary arteries, intake amlodipine prevents the development of thickening of the intima-media complex of the carotid arteries, reduces mortality from stroke, myocardial infarction, the use of thrombolytic drugs (TLP), coronary artery bypass grafting; therapy reduces the number of hospitalizations for the progression of CHF (chronic heart failure) and unstable angina pectoris, reduces the frequency of interventions that restore coronary blood flow.

Amlodipine-Borimed does not increase the likelihood of mortality or the development of complications leading to death in patients with CHF III – IV functional classes according to the NYHA (New York Heart Association) classification against the background of combination therapy with diuretics, digoxin and ACE inhibitors (angiotensin converting enzyme). In patients with CHF of non-ischemic etiology of III – IV functional classes according to the NYHA classification, there is a risk of pulmonary edema due to the use of amlodipine.

Pharmacokinetics

The main pharmacokinetic characteristics of amlodipine:

• absorption: after oral administration, amlodipine is slowly absorbed from the digestive tract. The average absolute bioavailability of the substance is 64%, C _max (maximum concentration) in the blood serum is noted after 6-9 hours. C _ss (equilibrium concentration) is reached after 7-8 days from the start of therapy. Food intake has no effect on the absorption of amlodipine;
• distribution in tissues and organs: V _d (average volume of distribution), equal to 21 l / kg of body weight, indicates that amlodipine is mainly found in tissues, a smaller part of it enters the blood, in which up to 95% of the substance binds to plasma proteins; the substance passes through the blood-brain barrier; not removed by hemodialysis;
• metabolism: amlodipine is metabolized in the liver actively, but slowly; its metabolites do not possess significant pharmacological activity; the effect of the first passage through the liver is practically absent;
• excretion: T _1/2 (half-life) after a single dose is 35-50 hours, after repeated administration, T _{1/2 is} established within 45 hours. Up to 60% of the dose taken orally is excreted by renal elimination, mainly in the form of metabolites, unchanged in this way about 10% comes out; with bile through the intestine, 20 to 25% of amlodipine taken orally is excreted. The total clearance is about 0.42 l / h / kg (0.116 ml / s / kg or 7 ml / min / kg).

Pharmacokinetic properties of Amlodipine-Borimed in special groups of patients:

• elderly patients over the age of 65 years: the rate of excretion of amlodipine is reduced in comparison with younger patients, T _1/2 increases to 65 hours, but this has no clinical effect on therapy;
• patients with hepatic insufficiency: an increase in T _1/2 to 60 hours suggests that prolonged use of the drug can lead to an increase in the accumulation of amlodipine in the body;
• patients with renal failure: changes in the level of amlodipine in blood plasma do not correlate with the degree of renal failure. There is a possibility of a slight increase in T _1/2, which does not significantly affect the pharmacokinetics of the substance.

Indications for use

Amlodipine-Borimed is used for hypertension as the drug of choice for monotherapy with antihypertensive drugs or as part of a combination treatment.

The drug is also used for the treatment of stable exertional angina and vasospastic angina (Prinzmetal's angina), including with the patient's immunity to nitrates or β-blockers.

Contraindications

Absolute:

• shock, including cardiogenic;
• severe arterial hypotension (decrease in systolic blood pressure by more than 20% from the baseline / usual value or less than 90 mm Hg);
• heart failure with unstable hemodynamic parameters in the period after acute myocardial infarction;
• unstable angina (except for Prinzmetal's angina);
• clinically significant aortic stenosis;
• obstruction of blood flow LVOT (left ventricular outflow tract), including severe aortic stenosis;
• children and adolescents up to 18 years old;
• periods of pregnancy and breastfeeding;
• established hypersensitivity to amlodipine, other dihydropyridine derivatives or auxiliary components of the drug.

Amlodipine-Borimed is recommended to be used with caution in case of heart failure, aortic stenosis, CHF of non-ischemic etiology of III-IV functional classes according to NYHA classification, acute myocardial infarction (and also within one month after it), arterial hypotension, simultaneously with inhibitors / inducers of the isoenzyme CYP3A4, with impaired renal / liver function, sick sinus syndrome (with severe bradycardia, tachycardia), mitral stenosis, hypertrophic obstructive cardiomyopathy, as well as in old age.

If you have at least one of the above diseases, you should consult your doctor before taking the drug.

Amlodipine-Borimed, instructions for use: method and dosage

Amlodipine-Borimed tablets are intended for oral administration. They are taken once a day, at the same time, with sufficient water (about 100 ml). The effectiveness of the drug does not depend on food intake.

Recommended dosage for the treatment of arterial hypertension and angina pectoris: the initial dose is 5 mg 1 time / day. If the therapeutic effect is absent within 2-4 weeks, the dose can be gradually increased to 10 mg / day, taken once.

When the patient missed the current dose of the Amlodipine-Borimed tablet, the dose should not be doubled. But it is important to consider that in this case, a temporary decrease in the effectiveness of treatment is possible.

Side effects

Taking Amlodipine-Borimed tablets can cause the following adverse reactions from systems and organs [frequency according to the WHO (World Health Organization) classification: very often - not less than 10%; often - 1-10%; infrequently - 0.1–1%; rarely - 0.01-0.1%; extremely rarely - less than 0.01%, including individual messages; frequency unknown - based on available data it is impossible to determine the frequency of occurrence of adverse events]:

• central nervous system: often - headache (especially at the beginning of treatment), increased fatigue, dizziness, drowsiness; infrequently - increased excitability, general malaise, peripheral neuropathy, hypesthesia / paresthesia, tremors, mood lability, insomnia, unusual dreams, anxiety, depression; extremely rare - apathy, migraine, agitation, ataxia, asthenia, amnesia, increased sweating; frequency unknown - extrapyramidal disorders;
• cardiovascular system: often - flushes of blood to the skin of the face, palpitations; infrequently - a significant decrease in blood pressure; extremely rare - shortness of breath, fainting, vasculitis, development or worsening of CHF, orthostatic hypotension, cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), chest pain, myocardial infarction, edema of the lower extremities, pulmonary edema;
• digestive system: often - abdominal pain, nausea; infrequently - constipation / diarrhea, vomiting, flatulence, dyspepsia, thirst, dryness of the oral mucosa, anorexia; rarely - increased appetite, gingival hyperplasia; extremely rarely - gastritis, jaundice, pancreatitis (caused by cholestasis), increased activity of hepatic transaminases, hyperbilirubinemia, hepatitis;
• hematopoietic and lymphatic systems: extremely rarely - leukopenia, thrombocytopenia, thrombocytopenic purpura;
• reproductive system and mammary gland: infrequently - impotence, gynecomastia;
• urinary system: infrequently - painful urination, frequent urination, nocturia; extremely rare - polyuria, dysuria;
• respiratory system: infrequently - rhinitis, shortness of breath; extremely rare - cough;
• skin and subcutaneous fat: rarely - dermatitis; extremely rare - xeroderma, alopecia, cold sweat, changes in skin pigmentation;
• musculoskeletal system: infrequently - myalgia, arthralgia, muscle cramps, arthrosis, back pain; rarely - myasthenia gravis;
• immune system: extremely rarely - itchy skin, rash (including maculopapular or erythematous rash, urticaria), erythema multiforme, angioedema;
• metabolism: extremely rare - hyperglycemia;
• sense organs: infrequently - diplopia, ringing in the ears, disturbance of accommodation, conjunctivitis, eye pain, xerophthalmia; extremely rare - parosmia;
• other reactions: infrequently - weight loss / increase, pain of unspecified localization, nosebleeds.

In case of aggravation of any of the above side effects or the development of other negative reactions of the body while taking Amlodipine-Borimed, you should consult a doctor.

Overdose

A symptom of an overdose of amlodipine is a pronounced decrease in blood pressure with the subsequent development of excessive peripheral vasodilation and reflex tachycardia (in especially difficult cases with severe and persistent arterial hypotension, up to shock and death).

For the treatment of intoxication, the patient is recommended to wash the stomach, give activated charcoal (preferably within the first 2 hours after the overdose), then lay the patient down, raising his legs to improve blood flow to the head. After that, it is necessary to monitor the indicators of heart and lung function, support the work of the cardiovascular system, control the BCC (circulating blood volume) and urine output. In order to restore vascular tone, vasoconstrictor agents are used (if there are no contraindications to their use). To eliminate the consequences of calcium channel blockade, calcium gluconate is administered intravenously.

Hemodialysis is ineffective for the elimination of amlodipine.

special instructions

When taking amlodipine, it is necessary to ensure control of body weight and sodium intake, the patient is advised to follow an appropriate diet.

No special effects were registered with the first administration of Amlodipine-Borimed.

The drug should be discontinued by gradually reducing the dose, since abrupt withdrawal increases the risk of worsening angina pectoris.

In order to prevent bleeding, soreness and gingival hyperplasia during treatment, you should maintain oral hygiene, brush your teeth and visit your dentist regularly.

Amlodipine has no effect on the plasma concentration of K ⁺ ions, triglycerides, glucose, total cholesterol, LDL (low density lipoprotein), uric acid, nitrogen and urea creatinine.

Women of fertile age during therapy with amlodipine require reliable methods of preventing pregnancy.

Patients with chronic heart failure of III – IV functional classes according to NYHA classification should take into account that when using the drug, they may develop pulmonary edema.

In acute myocardial infarction, Amlodipine-Borimed is taken only after the restoration of hemodynamic parameters.

If therapy with amlodipine is necessary for liver failure, patients need to provide medical supervision.

In elderly patients, the T _{1/2 of} amlodipine may increase and its clearance may decrease. Such changes in pharmacokinetic parameters do not require dose adjustment of Amlodipine-Borimed, but patients must be carefully monitored during treatment.

In case of severe liver dysfunction, patients of short stature and patients with low body weight may need to reduce the dose of the drug.

In case of impaired renal function, the patient's condition should be monitored during the period of taking amlodipine.

The effectiveness and safety of drug therapy in hypertensive crisis have not been established.

Influence on the ability to drive vehicles and complex mechanisms

Despite the fact that while taking Amlodipine-Borimed, there was no negative effect on the psychophysical state of the patient, due to a possible strong decrease in blood pressure, the development of drowsiness, dizziness and other side effects, it is important to be careful when driving vehicles or other complex mechanisms, especially at the beginning of the course and when the dose is increased.

Application during pregnancy and lactation

It is contraindicated to use Amlodipine-Borimed for the treatment of pregnant and breastfeeding women.

The fetotoxic and embryotoxic effects of amlodipine have not been established in experimental studies. Prescribing the drug during pregnancy is allowed only if absolutely necessary, when the benefits of therapy for the mother significantly outweigh the potential risk to the growth and development of the fetus.

There are no data indicating the excretion of amlodipine in breast milk, but it is reliably known that other BMCCs, dihydropyridine derivatives, are released during lactation. If a woman who is breastfeeding requires the appointment of Amlodipine-Borimed, the question of completing breastfeeding should be decided.

Pediatric use

In pediatric practice, the use of Amlodipine-Borimed for the treatment of children and adolescents under the age of 18 is contraindicated, since the effectiveness and safety of the drug in this age category of patients have not been established.

With impaired renal function

In the treatment of patients with renal insufficiency, amlodipine is used in usual doses.

For violations of liver function

Despite the fact that the T _{1/2 of} amlodipine, like all BMCCs, increases with impaired liver function, this usually does not require dose adjustment of Amlodipine-Borimed.

Use in the elderly

When treating elderly patients, there is no need to adjust the dose of Amlodipine-Borimed.

Drug interactions

Amlodipine-Borimed in the treatment of arterial hypertension can be safely used in conjunction with α-blockers, thiazide diuretics, ACE inhibitors. When treating patients with stable angina pectoris, the drug can be used in combination with other antianginal agents, for example, with prolonged / short-acting nitrates.

Possible pharmacological interaction of amlodipine with other medicinal substances (drugs) used simultaneously:

• non-steroidal anti-inflammatory drugs, including indomethacin: amlodipine belongs to the third generation of BMCC and does not show clinically significant interactions when used together with the listed drugs;
• thiazide and loop diuretics, ACE inhibitors, nitrates: capable of enhancing the antianginal and hypotensive effect of BMCC, including amlodipine;
• α ₁ - adrenergic blockers, β-adrenergic blockers, neuroleptics: potentiate the hypotensive effect of BMCC;
• erythromycin: increases the C _{max of} amlodipine in elderly patients by 50%, in young patients by 22%;
• β-blockers: increase the risk of exacerbation of heart failure;
• amiodarone, quinidine, other antiarrhythmic drugs that cause prolongation of the QT interval: when studying amlodipine, a negative inotropic effect was usually not observed, but it is recommended to take into account that some BMCA can potentiate the severity of the negative inotropic effect of these drugs;
• sildenafil (with a single dose of 100 mg): in the case of treatment of patients with arterial hypertension, it does not affect the pharmacokinetic parameters of amlodipine;
• atorvastatin (at a dose of 80 mg): repeated administration of amlodipine at a dose of 10 mg does not cause significant changes in the pharmacokinetics of atorvastatin;
• ethanol (alcoholic beverages, preparations containing ethyl alcohol): single and repeated use of amlodipine at a dose of 10 mg does not affect the pharmacokinetics of ethanol;
• ritonavir, other antiretroviral drugs: increase the plasma level of BMCC, including amlodipine;
• isoflurane and drugs of the neuroleptic group: increase the hypotensive effect of dihydropyridine derivatives;
• calcium preparations: able to reduce the effect of BMCC;
• lithium preparations: can enhance such reactions of amlodipine neurotoxicity as ataxia, nausea, vomiting, diarrhea, tinnitus, tremors;
• cyclosporine: does not alter the pharmacokinetics of amlodipine;
• digoxin: amlodipine does not affect the concentration of digoxin in the blood serum and its renal clearance;
• warfarin: its effect (prothrombin time) does not change significantly when used simultaneously with amlodipine;
• cimetidine: does not affect the pharmacokinetics of amlodipine;
• grapefruit juice (240 mg): when taken simultaneously with amlodipine (orally) at a dose of 10 mg, no significant changes in the pharmacokinetics of the latter were observed;
• aluminum and / or magnesium-containing antacids: with a single dose, they do not significantly affect the pharmacokinetics of amlodipine;
• digoxin, phenytoin, warfarin and indomethacin (in vitro): amlodipine has no effect on their binding to blood plasma proteins.

When, while taking Amlodipine-Borimed, there is a need to use other medicines, you must first consult with a specialist.

Analogs

Amlodipine-Borimed analogs are Amlodipine, Amlodipine Sandoz, Amlodipine-Biocom, Amlodipine-Prana, Amlodipine-Teva, Amlodipharm, Amlocard-Sanovel, Amlong, Amlonorm, Amlorus, Amlotop, Vero-Amlodipine, Kalchek, Kardilskelopin, Omlodipine, Nor, Tenox et al.

Terms and conditions of storage

Store at temperatures up to 25 ° C in a place protected from light and moisture, out of reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Amlodipine-Borimed

Various pharmaceutical companies produce a lot of drugs, in the name of which they use the name of the active substance - amlodipine, so it is difficult to separately highlight the reviews about Amlodipine-Borimed. Patients practically do not separate the drugs by manufacturer, indicating in general that amlodipine is a good drug that stably lowers blood pressure and allows you to control it for a long time.

The most common disadvantages are swelling of the legs, mainly in the ankles and feet. This is often a rather severe problem, due to which some patients have to interrupt therapy and switch to alternative antihypertensive drugs.

Experts do not recommend using conventional diuretics to relieve swelling caused by amlodipine. If the swelling does not impair the quality of life of patients, doctors advise learning to live with this side effect, since it is a common reaction to this drug. Otherwise, you need to contact a cardiologist or therapist to replace it.

The price of Amlodipine-Borimed in pharmacies

The approximate price of Amlodipine-Borimed, for a package containing 30 tablets, can be: dosage 5 mg - 29 rubles; dosage 10 mg - 39 rubles.

Amlodipine-Borimed: prices in online pharmacies

Drug name Price Pharmacy

Amlodipine-Borimed 5 mg tablets 30 pcs. 28 RUB Buy

Amlodipine-Borimed 10 mg tablets 30 pcs. RUB 40 Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!